Interoperable insulin pump gets US FDA nodApril 9, 2019
The US FDA approved Tandem Diabetes Care’s t: Slim X2 insulin pump with interoperable technology for delivering insulin under the skin.
Referred to as an alternate controller enabled (ACE) infusion pump, it allows patients to tailor diabetes management to their individual device preferences.
The interoperable t: Slim X2 pump works by delivering insulin under the skin at set or variable rates. It can be digitally connected to automatically communicate with and receive drug dosing commands from other diabetes management devices, such as AID systems. AID systems typically consist of a pump, CGM, and software to control the system.
The t: Slim X2 insulin pump was reviewed through the de novo pathway.
The FDA reviewed interoperable t: Slim X2 pump performance data demonstrating that the device can dose insulin accurately and reliably and at the rates and volumes programmed by the user. The FDA also assessed the ability of the pump to communicate with external devices with appropriate reliability, cybersecurity and fail-safe modes, Tandem said